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PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel

Pharmacokinetics Clinical Trial

Official title:
A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated With 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel

Clinical Trial Summary

A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations

Clinical Trial Description

A Randomized, Double-Blind, Phase 1b Study in Healthy HIV-Negative Women to Evaluate the Pharmacokinetics, Safety, and Bleeding Patterns Associated with 90-Day Use of Core-Sheath Vaginal Rings Releasing Dapivirine and Levonorgestrel ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05041699
Study type Interventional
Source International Partnership for Microbicides, Inc.
Contact John Steytler, MBChB
Phone 27-21-860-2358
Email jsteytler@ipmglobal.org.za
Status Recruiting
Phase Phase 1/Phase 2
Start date June 20, 2022
Completion date December 31, 2024
View Details
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